VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics has recalled the VITROS 3600 Immunoassay System with Software V3.3.2 and below due to a luminometer malfunction that may prevent the system from processing MicroWell assays. The affected product code is 6802783, and 267 units have been distributed worldwide, including throughout the United States and 22 other countries in Europe, Asia, South America, and Oceania.
The recalled systems have serial numbers 36001160 and above. The source document does not specify what actions affected consumers or facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Reason for recall: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Distribution: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom. Quantity: 267 units Lot/code info: Serial Numbers: 36001160 & above UDI: 10758750002979)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.